Focus : Identifying and accessing patients with chronic venous disease: the large-scale VCP International Study



Eberhard RABE,MD, PhD
Department of Dermatology – University of Bonn
Bonn, GERMANY

Identifying and accessing patients with chronic venous disease: the large-scale VCP International Study

by E. Rabe,Germany



Chronic venous disease (CVD) is defined as morphological and functional abnormalities of the venous system of long duration, manifested either by symptoms and signs indicating the need for investigations and/or care. The impact of CVD in the general population is often underestimated and not well recognized by health systems. In recent studies and according to the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification, the C0 and C1 classes together are prevalent in more than 60% of the population. Varicose veins (C2) are prevalent in more than 20%. Skin changes, including venous ulcers, are present in less than 10% of the population. For many countries, no epidemiologic data exist. The worldwide Vein Consult Program aims to assess the prevalence of CVD and provide a picture of the typical adult patient and the management of their disease, in varying geographical areas. This is the largest ever CVD detection program to be undertaken. The Vein Consult Program is being carried out under the auspices of the International Union of Phlebology with the support of an unrestricted grant from Servier. More than 4500 selected general practitioners are participating, and it is estimated that they will screen approximately 95 000 patients. In step 1 of the program, general practitioners screen patients whom they are consulting for any medical reason. Step 2 is a follow-up consultation with a venous specialist. Preliminary results from 69 866 screened patients from 13 countries worldwide are available.

Medicographia. 2011;33:320-324 (see French abstract on page 324)

Chronic venous disease (CVD) is defined as morphological and functional abnormalities of the venous system of long duration, manifested either by symptoms and signs indicating the need for investigations and/or care.1 Typical symptoms associated with CVD are heavy legs, leg pain, sensation of swelling, pins and needles in the legs, and itching. Typical signs of chronic venous insufficiency (CVI) are varicose veins, edema, skin changes (like pigmentation and atrophy), and leg ulcers. CVD is graded according to the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification, which provides an orderly framework for diagnosis. Clinical signs in the affected legs are categorized as one of seven classes ranging from C0-C6 (Table I), and the limbs of any clinical class may be classified symptomatic or asymptomatic.2 CVD is a progressive disease that can lead to diseaserelated complications like venous ulceration. It is a result of abnormally raised venous pressure caused by venous inflammation, which can cause the disease to progress from early symptoms to vessel wall deterioration and damaged venous valves, which in turn lead to the appearance of signs of CVD such as varicose veins, skin changes, and leg ulceration.3,4 CVD is also a risk factor for the development of thromboembolic complications. Disease progress can be prevented by early detection and intervention. The impact of CVD in the general population is often underestimated and not well recognized by health systems. It is also often overlooked in primary care and cardiovascular care because of an underappreciation of its scale and of the impact of the disease.5

Table I
Table I. CEAP classification: clinical classes and definitions.

Abbreviation: CEAP, Clinical-Etiological-Anatomical-Pathophysiological.

Prevalence of chronic venous disease

In the last few decades, epidemiological CVD studies have been performed in many countries worldwide, mainly focusing on varicose veins.6-13 The results have not been homogeneous; different definitions of CVD, different age groups, and different methods of investigation in these studies led to differing results. In recent years, a few studies based on the CEAP classification have been published.14-19 In the CEAP-based epidemiological studies, the reported prevalence is similar for most items (Table II). Classes C0 and C1 together are prevalent in more than 60% of the population. Varicose veins (C2) are prevalent in more than 20%, with a higher prevalence in women. Skin changes due to venous diseases, including venous ulcers, are present in less than 10% of the population with no significant gender differences. Older age, family history of varicose veins, female gender, and pregnancy are established risk factors for varicose veins; obesity is an important additional risk factor for CVI. Unfortunately, such data is only available for a few countries, and the epidemiologic situation in many regions of the world remains unclear.

Table II
Table II (above and left). Prevalence of CEAP classes C0-C6 in recent studies in Western countries. Based on references 14 to 19.

Abbreviation: CEAP, Clinical-Etiological-Anatomical-Pathophysiological.

Quality of life and burden of chronic venous disease

CVD can negatively affect patients’ quality of life (QOL), as it is a painful and disabling disease that can restrict physical functioning and mobility and that is associated with depression and social isolation.4 In consequence, CVD can result in limitation to daily activities, decreased productivity at work, and patients needing to take sick leave, as well as having a negative effect on their self-esteem. Disease severity appears to be a good indicator of QOL. The higher the CEAP clinical class, the poorer the disease-specific QOL, as demonstrated by low scores for physical and social functioning in QOL questionnaires.4

One such questionnaire, CIVIQ (ChronIc Venous dIsease Questionnaire), is a 20-item questionnaire that provides a global index score and a profile in four different categories: pain, physical, psychological, and social functioning. It is valid across a range of different languages and cultures.20 A shortened version, CIVIQ-14, has been used in the Vein Consult Program.

CVD represents a significant socioeconomic burden in terms of health-care costs due to its high prevalence, the costs of investigation and treatment of complications, and lost working days.3 The overall cost of venous disease in Germany was €2.18 billion in 2006.21 A recent evaluation in Germany revealed the mean total yearly cost of an ulcer patient to be almost €10 000.22

International Union of Phlebology

The International Union of Phlebology (Union Internationale de Phlébologie [UIP]), founded in 1959, is an association of national phlebology societies from Europe, North America, Latin America, Asia, Africa, Australia, and New Zealand. The UIP represents 50 phlebology societies in 47 countries. The UIP is governed by its Executive Committee consisting of the president, the president elect/the past president, 5 vice presidents, a general secretary, an assistant general secretary, and a treasurer.

The aims of the UIP are:
_ to strengthen the links between societies or associations, either existing or to be created, which have a special interest in the study and the treatment of CVDs
_ to spread recommendations on the teaching of phlebology, as well as the training and continuing medical education of phlebologists
_ to promote consensus on all aspects of CVD
_ to encourage studies and research on disorders of venous origin
_ to promote joint meetings or international congresses
_ to encourage the creation and activities of national societies or associations and to encourage membership of the UIP. The UIP’s three main areas of focus are science, education, and communication.

The UIP encourages ongoing scientific research in phlebology to help answer some of themany questions that still exist in venous disease. One of the important goals is to gain more information on venous epidemiology and on the burden of disease worldwide. For this reason, the UIP is cooperating with Servier on the Vein Consult Program.

Vein Consult Program

The Vein Consult Program is an international educational effort to raise awareness of CVD amongst physicians, patients, the scientific community, and health authorities. The worldwide screening program aims to assess the prevalence of CVD and provide a picture of the typical adult patient and the management of their disease, in varying geographical areas. This is the largest ever CVD detection program to be undertaken, and it will help to evaluate how general practitioners (GPs) and venous specialists manage patients with CVD and to better understand at which stage of the disease specialists take over from GPs in the management process. The program aims to detect CVD early, with the goal of improving the process of management of this chronic disease. It will also assess the impact of CVD on the QOL of patients, healthcare resources, and the economy.

The Vein Consult Program is being carried out under the auspices of the UIP with the support of an unrestricted grant from Servier. The program will be scientifically validated by the UIP via its operational board members and scientific advisory committee. The research is being coordinated in participating countries by national societies that are affiliated to the UIP. In each country, a local research organization will be responsible for data entry and its validation. An international research organization will then pool all national data and be responsible for statistical analysis of these data, under the supervision of the UIP’s scientific advisory committee.

The Vein Consult Program, which started in 2009, is an international observational, multicenter, descriptive survey of CVD. More than 4500 selected GPs are participating, and it is estimated that they will screen approximately 95 000 patients (Table III). In step 1 of the program, GPs screen patients whom they are consulting for any medical reason (except an emergency) and assess their suitability for inclusion in the program. There are several criteria: the patient (male or female) must be over 18 years old; they must be informed of their involvement in a screening program and accept to take part; they must be informed that they have the right to refuse to participate fully or partly; and they should not be consulting for an emergency or for an acute episode of an ongoing event. Patients need to be enrolled consecutively within a short period of time.

Table III
Table III. Initial procedures in the Vein Consult Program.

If the patient fits the criteria, participating GPs need to complete a standardized case report form assessing their patient’s history, list any CVD risk factors, screen for CVD symptoms, and perform a routine leg examination. The patient is then classified according to the CEAP clinical classification. If the patient shows signs of having any CVD symptoms and the GP considers them to be eligible to participate in step 2 of the program, the patient will next be asked to complete a short, self-administered, 14-item QOL questionnaire, CIVIQ-14. The GP will then recommend a follow-up consultation with a venous specialist.

Step 2 is the follow-up consultation with a venous specialist. In step 2 of the Vein Consult Program, 500 selected specialists will potentially follow up 6500 patients. For each patient, the specialists will complete a 21-item questionnaire to establish the patient’s history of CVD and CVD risk factors, carry out a lower leg examination, and assess whether treatment is required. The results from this program will help to characterize the typical CVD patient and to establish a better understanding of the prevalence of this chronic disease in the participating countries.

_ Preliminary results
Some 4500 GPs from 20 countries are involved in step 1of the Vein Consult Program. The preliminary results from a total of 69866 screened patients from Brazil, France, Georgia, Hungary, Mexico, Pakistan, Romania, Russia, Serbia, Singapore, Slovakia, Spain, and the United Arab Emirates are already available. Seventeen percent of these patients consulted a GP especially for venous leg problems. Signs of C1-C6 were present in 59% of the population, while 17% had venous symptoms without clinical signs of venous disease (C0S).

The prevalence of CVD in its early stages, stages C1-C3, was significantly higher in women than in men, whereas in stages C0S, C4, C5, and C6, there was no statistical significant difference between the sexes. The mean number of symptoms increased with increasing classification from stage C2-C5. Leg pain was significantly more prevalent in the higher classification stages (C3-C6) in 18%-19%. The CIVIQ-14 score increased significantly with severity of CVD. Patients in the C4- C6 stages had a significantly worse QOL compared with those in the C1-C2 stages. Patients with venous symptoms had a worse QOL in CIVIQ-14 than those without symptoms.

Summary

The Vein Consult Program, a cooperative venture between the International Union of Phlebology and Servier, is the largest ever CVD detection program to be undertaken with 95 000 patients from 20 countries. The program will help us to better understand the prevalence and risk factors of CVD, the impact of CVD on the QOL of patients and health resources, and the burden of the disease on the patient and on the economy. The Vein Consult Program will also help to increase the awareness of CVDs among health-care professionals and officials, politicians, and insurance companies. This is vital if we are to prevent an upcoming increase in the prevalence of CVD in the general population caused by demographic changes (eg, an increasing elderly population) and by changes in lifestyle (eg, an increasing prevalence of obesity). The issue of improved awareness needs to be urgently addressed. _

References
1. Eklöf B, Perrin M, Delis KT, Rutherford RB, Glovizki P. Updated terminology of chronic venous disorders: The VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009;49:498-501.
2. Eklöf B, Rutherford RB, Bergan JJ, et al; American Venous Forum’s International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous venous disorders. A consensus statement. J Vasc Surg. 2004;40:1248-1252.
3. Nicolaides AN, Allegra C, Bergan JJ, et al. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008;27:1-59.
4. Bergan JJ, Schmid-Schönbein GW, Coleridge-Smith PD, Nicolaides AN, Boisseau MR, Eklöf B. Chronic venous disease. N Engl J Med. 2006;355:488-498.
5. Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005;111: 2398-2409.
6. Beebe-Dimmer JL,Pfeifer J, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005;15:175-184.
7. Evans CJ, Fowkes FGR, Hajivassiliou CA, Harper DR, Ruckley C. Epidemiology of varicose veins. A review. Int Angiol. 1994;13:263-270.
8. Evans CJ, Fowkes FGR, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999;53:149-153.
9. Fischer H. (Hrsg.), Venenleiden – Eine repräsentative Untersuchung in der Bundesrepublik Deutschland ( Tübinger Studie ). München: Urban und Schwarzenberg; 1981.
10. Fowkes FGR, Evans CJ, Lee AJ. Prevalence and risk factors of chronic venous insufficiency. Angiology. 2001;52:S5-S15.
11. Heit JA, Rooke TW, Silverstein MD, et al. Trends in the incidence of venous stasis syndrome and venous ulcer: a 25-year population-based study. J Vasc Surg. 2001;33:1022-1027.
12. Ruckley CV, Evans CJ, Allan PL, Lee AJ, Fowkes FG. Chronic venous insufficiency: clinical and duplex correlations. The Edinburgh Vein Study of venous disorders in the general population. J Vasc Surg. 2002;36:520-525.
13. Widmer LK, Stählin HB, Nissen C, Da Silva A (Hrsg.). Venen-, Arterien-Krankheiten, koronare Herzkrankheit bei Berufstätigen, Prospektiv-epidemiologische Untersuchung Baseler Studie I-III 1959-1978. Bern StuttgartWien: Verlag Hans Huber.
14. Rabe E, Pannier-Fischer F, Bromen K, et al. Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung. Phlebologie. 2003;32;1-14.
15. Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004;40:650-659.
16. Chiesa R, Marone EM, Limoni C, Volonté M, Schaefer E, Petrini O. Demographic factors and their relationship with the presence of CVI signs in Italy. The 24- cities cohort study. Eur J Vasc Endovasc Surg. 2005;30:674-680.
17. Chiesa R, Marone EM, Limoni C, Volonté M, Schaefer E, Petrini O. Chronic venous insufficiency in Italy: The 24-cities-cohort study. Eur J Vasc Endovasc Surg. 2005;30:422-429.
18. Criqui MH, Jamosmos JM, Fronek AT, et al. Chronic venous disease in an ethnically diverse population. The San Diego Population Study. Am J Epidemiol. 2003;158:448-456.
19. Jawien A, Grzela T, Ochwat A. Prevalence of chronic venous insufficiency inmen and women in Poland: multicenter cross-sectional study in 40 095 patients. Phlebology. 2003;18:110-121.
20. Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Angiology. 2002;53:245-256.
21. Rabe E, Pannier F. Societal costs of chronic venous disease in CEAP C4, C5, C6 disease. Phlebology. 2010;25 suppl 1:64-67.
22. Purwins S, Herberger K, Debus ES, et al. Cost-of-illness of chronic leg ulcers in Germany. Int Wound J. 2010;7:97-102.

Keywords: Vein Consult Program; chronic venous disease; CEAP; CIVIQ; epidemiology; International Union of Phlebology; UIP